Trial Outcomes & Findings for Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE) (NCT NCT04620356)
NCT ID: NCT04620356
Last Updated: 2024-12-06
Results Overview
Average number of wet nights
COMPLETED
NA
105 participants
Last week of the 4-week intervention period
2024-12-06
Participant Flow
participants were recruited both from the community and from primary and tertiary care centers.
Assessed for eligibility (n = 116). Excluded pré randomization(n = 11) * Not meeting inclusion criteria (n = 1) * Not meeting randomisation criteria (n = 9) * Severe non-compliance (n = 1)
Participant milestones
| Measure |
DryNites Arm
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
70
|
|
Overall Study
COMPLETED
|
31
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Baseline characteristics by cohort
| Measure |
DryNites Arm
n=35 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=70 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
|
Total
n=105 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
5.4 years
STANDARD_DEVIATION 1.22 • n=5 Participants
|
5.6 years
STANDARD_DEVIATION 1.09 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 1.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Last week of the 4-week intervention periodAverage number of wet nights
Outcome measures
| Measure |
DryNites Arm
n=34 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=66 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Wet Nights
|
2.4 wet nights per week
Standard Deviation 2.21
|
4.6 wet nights per week
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Assessment will be done at each study clinic visit (Day 56 +/- 7)The PinQ will be used to assess the child's QoL. The PinQ is a validated cross-cultural continence-specific paediatric QoL questionnaire to assess children with bladder dysfunction, developed by Bower el al (Bower et al. 2006). It is available as self-rated and proxy versions. This will be completed by the child themselves in the older participant group and will be completed by the parent/carer on behalf of the child in the younger participant group. The PinQ measures the emotional impact that urinary incontinence has on a child. It consists of 20 urinary incontinence QoL related questions divided in 2 dimensions: intrinsic (14 items) and extrinsic (6 items), which are graded on a scale of 0 to 4 (0=No, 1=Hardly ever,2=Sometimes, 3=Often, 4=All the time) with a score range of 0 to 80. The total score indicates the impact urinary incontinence has on the child's QoL with the higher scores indicating a more significant effect.
Outcome measures
| Measure |
DryNites Arm
n=29 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=58 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)
|
12.9 score on a scale
Standard Deviation 8.17
|
15.2 score on a scale
Standard Deviation 10.83
|
SECONDARY outcome
Timeframe: Assessment will be done at each study clinic visit (Day 56 +/- 7)The WHOQoL-BREF questionnaire (WHO 1996) will be completed directly by the parent/carer. . The WHOQoL-BREF questionnaire is derived from a larger instrument, the WHOQoL-100. It includes 26 items, grouped in 4 domains: Physical Heath, Psychological, Social Relationships, and Environment, and 2 separate items asking the crespondent about overall perception of QoL (item 1) and an individual's overall perception of their health (item 2). The scores of items 3, 4 and 5, which are negatively phrased, need to be reversed. The mean score of items within each domain is used to calculate the domain scores, which are converted into a 0-100 scale. Higher scores denote higher QoL. Where more than 20% of data is missing from an assessment, the assessment should be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than 2 items are missing from the domain, the domain score should not be calculated
Outcome measures
| Measure |
DryNites Arm
n=29 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=62 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire
|
21.3 score on a scale
Standard Deviation 3.13
|
21.5 score on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Assessment will be done at each study clinic visit (Day 56 +/- 7)The Paeditric Daytime Sleepiness Scale (PDSS) questionnaire measures daytime sleepiness in children. It is comprised of 8 items assessing daytime sleepiness and rated on a 5-point scale with 0 = Never and 4 = Always/Very Often. The scale ranges from 0 to 32. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater daytime sleepiness. Higher scores indicate greater daytime sleepiness, and were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness.
Outcome measures
| Measure |
DryNites Arm
n=32 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=61 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Child Daytime Sleepiness as Assessed by PDSS Questionnaire
|
7.7 score on a scale
Standard Deviation 3.63
|
8.5 score on a scale
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Assessment will be done at each study clinic visit (Day 56 +/- 7 )The CIS questionnaire was used to assess the parents' sleep. It was completed directly by the parent/carer. The CIS consists of 20 statements on fatigue-related problems responders might have experienced in the past 2 weeks. A Likert scoring scheme from 1 to 7 ranging from 1-"no, that is not true" to 7-"yes, that is true" with items 2, 5, 6, 7, 8, 11, 12, 15 and 20 hold inverted scores. The total score ranges from 20 to 140. The questionnaire covers measures 4 dimensions of fatigue: Subjective fatigue severity (8 items), Concentration problems (5 items), Reduced motivation (4 items) and Physical activity (3 items). Dimensions can be analyzed separately, with higher scores indicating higher levels of subjective fatigue (8-56), reduced concentration (5-35), reduced motivation (4-28), and lower levels of physical activity (3-21). A total score over 76 is considered at risk of a fatigue disorder, while 36 provides the cutoff score on the subjective experience of fatigue sub-scale
Outcome measures
| Measure |
DryNites Arm
n=28 Participants
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=61 Participants
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)
|
43.7 score on a scale
Standard Deviation 16.88
|
46.1 score on a scale
Standard Deviation 22.75
|
Adverse Events
DryNites Arm
No Pants Arm
Serious adverse events
| Measure |
DryNites Arm
n=35 participants at risk
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=70 participants at risk
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Respiratory, thoracic and mediastinal disorders
subglottic laryngitis
|
0.00%
0/35 • 56 +/- 7 days
|
1.4%
1/70 • Number of events 1 • 56 +/- 7 days
|
Other adverse events
| Measure |
DryNites Arm
n=35 participants at risk
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
DryNites Pyjama Pants: DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
|
No Pants Arm
n=70 participants at risk
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.
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|---|---|---|
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Infections and infestations
genital candidiasis,
|
0.00%
0/35 • 56 +/- 7 days
|
1.4%
1/70 • Number of events 1 • 56 +/- 7 days
|
|
Respiratory, thoracic and mediastinal disorders
pharyngitis
|
0.00%
0/35 • 56 +/- 7 days
|
1.4%
1/70 • Number of events 1 • 56 +/- 7 days
|
|
Respiratory, thoracic and mediastinal disorders
subglottic laryngitis
|
0.00%
0/35 • 56 +/- 7 days
|
1.4%
1/70 • Number of events 1 • 56 +/- 7 days
|
|
Infections and infestations
pyrexia
|
0.00%
0/35 • 56 +/- 7 days
|
1.4%
1/70 • Number of events 1 • 56 +/- 7 days
|
|
Skin and subcutaneous tissue disorders
rash
|
2.9%
1/35 • Number of events 1 • 56 +/- 7 days
|
0.00%
0/70 • 56 +/- 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place